Characteristics of clinical trials authorized in Peru: 1995-2012

Authors

  • Gabriela Minaya Dirección General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud. Lima, Perú. Red Latinoamericana y del Caribe de Bioética, Organización de las Nacionaes Unidas para la Educación, la Ciencia y la Cultura (UNESCO). Montevideo, Uruguay. Médico infectóloga máster en Bioética.
  • Duilio Fuentes Dirección General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud. Lima, Perú. Red Latinoamericana y del Caribe de Bioética, Organización de las Nacionaes Unidas para la Educación, la Ciencia y la Cultura (UNESCO). Montevideo, Uruguay. médico internista máster en Bioética.
  • Cristian Obregón Dirección General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud. Lima, Perú. licenciado en Estadística.
  • Beatriz Ayala-Quintanilla Dirección General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud. Lima, Perú. médico Ginecoobstetra máster en Salud Pública PhD en Medicina.
  • Martín Yagui Dirección General de Investigación y Transferencia Tecnológica, Instituto Nacional de Salud. Lima, Perú. Ministerio de Salud. Lima, Perú. Médico epidemiólogo.

DOI:

https://doi.org/10.17843/rpmesp.2012.294.385

Keywords:

Clinical trials as topic, Biomedical research, Clinical research, Drug utilization, Provider-Sponsored Organizations, Health care coordination and monitoring, Peru

Abstract

Objective. To identify main characteristics of clinical trials (CT) authorized by the National Institute of Health (INS) of Peru from 1995 to August 2012. Material and methods. Cross-sectional study, which reviewed all records of CT submitted for review and possible approval by INS, whose data are part of the Peruvian Registry of Clinical Trials. We performed a descriptive analysis of the states of the CT approval and other characteristics. Results. 1475 clinical trials were assessed, of which 1255 (85.1%) were authorized. From 1 clinical trial officially registered in 1995, its quantity increased to 176 trials submitted in 2008, and then, declined to 128 in 2011. Among the approved CT, 64.1% was in Phase III. Oncology (22.4%), infectious diseases (15.5%) and endocrinology (12.7%) were the most studied specialties and a only 1.2% were for neglected tropical diseases. The oral hypoglycemic drugs, systemic antiviral and antineoplastic agents were the most studied investigational products. The transnational pharmaceutical industry was the main sponsor (87.1%) and executors (62.3%) of clinical trials were mostly in Lima. Conclusions. Clinical trials in Peru mainly focus on noncommunicable diseases and phase III studies. The pharmaceutical industry is the main sponsor. A very small number of authorized clinical trials in Peru were for neglected tropical diseases that shows little attention to the health problems in vulnerable populations.

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Published

2014-02-05

Issue

Section

Research Articles

How to Cite

1.
Minaya G, Fuentes D, Obregón C, Ayala-Quintanilla B, Yagui M. Characteristics of clinical trials authorized in Peru: 1995-2012. Rev Peru Med Exp Salud Publica [Internet]. 2014 Feb. 5 [cited 2024 May 27];29(4). Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/385

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